Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion

The University of Chicago

Status

Completed

Conditions

Chronic Total Occlusion

Treatments

Other: Directly measure microvascular function using direct coronary flow measurements

Study type

Interventional

Funder types

Other

Identifiers

NCT04226326

IRB19-0654

Details and patient eligibility

About

This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO. The study is designed to enroll 50 subjects with CTO in the span of 3 years. There will be a 6-month assessment of the outcomes of death and cardiovascular death. As the study includes FDA approved tests, there will be no safety endpoint per se, however there will be a mechanism for monitoring adverse events as will be described in detail.

Enrollment

4 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age ≥ 21 years
seen at University of Chicago Medical center with a planned PCI of a single CTO vessel
must have either stable angina or angina equivalent
must have a CTO with a clear donor vessel supplying most of the collaterals.

Exclusion criteria

subjects with a pacemaker or implantable cardioverter defibrillator
contraindication to cardiac MRI, adenosine, heparin, or nitroglycerin
cardiac transplantation
Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, given the risk of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF) associated with iodinated and gadolinium-based contrast agents, respectively, in patients with significant renal dysfunction
Women who may potentially be pregnant will receive a pregnancy test and be excluded if pregnant
Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity
Inability or refusal to consent for the study.